Modernizing the APQR Process
In the pharmaceutical industry, ensuring product quality is paramount to comply with regulatory standards. One critical aspect is the Annual Product Quality Review (APQR), a mandatory report for drug manufacturers to meet Good Manufacturing Practice (GMP) regulations and uphold the quality of their products. Honeywell Product Quality Review (HPQR) simplifies this process by offering a digital platform that streamlines the entire APQR workflow. From accessing essential data sources to generating a draft report incorporating multiple user reviews, HPQR facilitates a seamless journey towards final approval and generation of the APQR report. By digitizing and automating this process, HPQR not only saves time and resources but also enhances accuracy and compliance with industry regulations.
Improving Productivity and Accuracy
HPQR leverages automated data collection and approval workflows to enhance productivity and accuracy in product quality reviews. By automating complex statistical analyses of quality data, HPQR simplifies the report creation process, reducing the manual effort required while ensuring precise and insightful evaluations. Moreover, the platform allows for proactive reviews, enabling the creation of virtual or interim Product Quality Reviews to continuously monitor and assess the quality of products. This proactive approach helps in identifying and addressing potential issues early, ultimately contributing to improved product quality and compliance.
Ensuring Regulatory Compliance
Maintaining regulatory compliance is non-negotiable in the pharmaceutical industry, where adherence to stringent regulations like 21 CFR Part 11 is essential. HPQR supports companies in meeting these regulatory requirements by providing a secure and compliant digital environment for conducting product quality reviews. By centralizing all relevant data and documentation within the platform, HPQR helps streamline audits and inspections, ensuring that companies are well-prepared to demonstrate their compliance with regulatory standards. With features like cross-functional collaboration, HPQR promotes transparency and accountability across departments, facilitating efficient and compliant product quality review processes.